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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, personal
510(k) Number K122476
Device Name LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
Applicant
ANSELL HEALTHCARE PRODUCTS, LLC
4 LOS VERDES DRIVE
SAN LUIS OBISPO,  CA  93401
Applicant Contact DONNA DI GANGI
Correspondent
ANSELL HEALTHCARE PRODUCTS, LLC
4 LOS VERDES DRIVE
SAN LUIS OBISPO,  CA  93401
Correspondent Contact DONNA DI GANGI
Regulation Number884.5300
Classification Product Code
NUC  
Date Received08/14/2012
Decision Date 03/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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